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Health Advocate Support for Liver Transplant Complications (HEAL-Tx Pilot Trial)
N/A
Recruiting
Led By Sharad Wadhwani, MD, MPH
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 90 days, and 180 days
Awards & highlights
No Placebo-Only Group
Summary
This trial assesses an intervention to support pediatric liver transplant patients by facilitating medical care, finances and access to resources, with the goal to improve communication and self-management for better outcomes.
Who is the study for?
This trial is for children under 18 who have had a liver transplant. They and/or their guardians must understand English or Spanish, agree to the study's terms, and be chosen by the transplant team as suitable participants. It excludes adults, non-English/Spanish speakers, those unwilling to complete surveys, wards of the state, and non-US residents.
What is being tested?
The HEAL-Tx Pilot tests if adding a Health Advocate to the pediatric liver transplant team helps with care coordination, financial support like taxi vouchers, and linking families to community resources. The goal is to see if this improves self-care and communication between families and healthcare providers.
What are the potential side effects?
Since this trial involves a health advocate intervention rather than medication or medical procedures, traditional side effects are not expected. However, there may be indirect impacts on family dynamics or emotional responses that will be monitored.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 90 days, and 180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 90 days, and 180 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in caregiver experience
Secondary study objectives
A qualitative assessment of caregiver and healthcare provider satisfaction with the Health Advocate intervention.
Change in medication adherence using MLVI
The quality of health advocate interactions with the participants, healthcare team, and community-based resources.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
This is a single arm pilot intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Health Advocate
2017
N/A
~40
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,587 Previous Clinical Trials
14,901,166 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,448 Previous Clinical Trials
4,332,394 Total Patients Enrolled
Sharad Wadhwani, MD, MPHPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
520 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not speak English or Spanish.I am over 18 years old.I am under 18 and have had a liver transplant.My caregiver cannot or will not fill out the survey.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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